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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lubricant, Personal
510(k) Number K192204
Device Name Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant,
Applicant
Valencia Naturals, Inc.
9731 Topanga Canyon Pl.
Chatsworth,  CA  91311
Applicant Contact Louie Goryoka
Correspondent
Med-Device Consulting, Inc.
5804 Rainbow Hill Rd.
Agoura Hills,  CA  91301
Correspondent Contact Louie Goryoka
Regulation Number884.5300
Classification Product Code
NUC  
Date Received08/14/2019
Decision Date 11/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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